- Regulation based on science, risk assessment, and balancing of risks and benefits
- Different levels of precaution for different categories of products, depending largely to whom the act allocates the burden of proof
- For drugs, focus on safety and efficacy for intended use
- Adulteration and misbranding—two types of product defects
In the nineteenth century, there were no legal protections for workers, consumers, or others who lacked wealth and power. “Survival of the fittest” and “Buyer beware” were the hallmarks of the day. Around 1900, a few investigative journalists and other reformers began to shine the spotlight on corruption and inequities in our society. They were known as “muckrakers.”
One of those muckrakers was the novelist Upton Sinclair. He worked undercover in the Chicago stockyards, and then wrote an exposé called The Jungle. This book revealed terrible safety and sanitary conditions in the meatpacking industry, including incidents of workers falling into giant rendering vats and left to become part of the lard sold by the company. Sinclair cared mainly about the workers, but readers focused on his descriptions of filth and contamination. The public was alarmed about eating contaminated beef.
President Theodore Roosevelt sent trusted representatives to investigate, and they confirmed Sinclair’s accusations (except they didn’t observe any workers falling into rendering vats). Prompted by their report and a public outcry, Congress enacted the Meat Inspection Act and the Pure Food and Drug Act of 1906, which created the agency that would become, in 1930, the Food and Drug Administration.
The Food, Drug, and Cosmetic Act (FDCA)1 is among our oldest federal public health laws. Its purpose is to protect consumers from health risks, misinformation, and other pitfalls with respect to food, drugs, dietary supplements, cosmetics, tobacco. Its roots date back to 1906, but the act in substantially its present form was enacted in 1988. Before and since then, there have been numerous additions and amendments, often in response to public health crises.2
The act regulates foods, medical products such as therapeutic drugs, dietary supplements, and cosmetics. Tobacco was added to this list in 2009. All of these, except for cosmetics, will be discussed in this chapter. The FDCA establishes separate and quite different programs for each regulated commodity group. In particular, the programs vary with respect to degree of precaution exercised by Congress and the powers granted to the Food and Drug Administration. But regulation of all these commodities is based on science and risk assessment, and decisions generally involve balancing risks and benefits.
The act is implemented by the Food and Drug Administration (FDA), which is an agency within the Department of Health and Human Services (HHS). When the act refers to the administrator, it means the FDA administrator. When it refers to the secretary, it means the secretary of HHS.
Unlike many environmental acts, states do not jointly implement the federal law. However, the FDCA does not prohibit state regulation of the same matters, so long as state or local laws do not conflict with or undermine federal law.
The FDCA is intended to protect public health by ensuring that the foods consumers buy are safe, wholesome, and properly labeled.3 With regard to food, the act is moderately precautionary—though less so than for drugs. Regulation is science-based and relies on risk assessment and the balancing of risks and benefits. Regulation is directed primarily at those who introduce food products into commerce—manufacturers, processors, and importers. There are also regulations affecting sellers and others in the chain of supply. Farmers are affected by the provisions related to pesticide residues (see chapter 12, Federal Insecticide, Fungicide, and Rodenticide Act).
The act has two main approaches. First, it prohibits the sale of what it refers to as “adulterated” food. Second, it imposes certain label requirements, including a prohibition of what is called “misbranding.”
What Is Food?
This part of the act covers articles for food or drink for humans or animals, or components of such articles.4 The definition includes, for example, chewing gum, spices, coffee beans, and cooking oil. It does not include tobacco, which is now regulated by the act, but not as a food. Nor does it include wine.
Meat and poultry are major exceptions to foods regulated by the FDA—they are regulated by the Department of Agriculture (USDA). The borderline between these two agencies zigzags a bit. The FDA regulates eggs in the shell under its food program, but the Department of Agriculture regulates pasteurized egg products.5 Foods prepared and served in restaurants are mainly regulated by local health departments, not by the FDA.
Food safety is just one of the many examples for which cooperation among different federal and state agencies is crucial. An outbreak of disease due to food contamination is usually first detected by a local or state health department. Depending upon state law, the health department will have the authority to take immediate measures, such as closing a restaurant or food supplier. Involvement of the federal Centers for Disease Control (CDC) is often requested, particularly if the state’s own public health laboratory does not have sufficient expertise to readily identify the causative agent or if the outbreak affects multiple states. Federal regulatory agencies—most commonly the FDA, the EPA, or the Department of Agriculture’s Food Safety and Inspection Service—may be brought in through their state counterparts or through the CDC, to help search for the origins of the contaminated foods, test for causative agents, and recall the foods. In addition to regulatory action, a food-borne disease outbreak subjects the responsible party to tort lawsuits by individuals who suffer harm.
The FDCA prohibits the sale of adulterated foods.6 This term encompasses a wide variety of threats to public health. It refers not only to the actual content of food, but also the conditions to which the food is exposed before reaching the consumer.
In general, a food is deemed adulterated if it contains any “poisonous or deleterious substance which may render it injurious to health.” Further, the term “adulterated” applies to any food that may be injurious to health because “it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food.” Note that the law does not require the FDA to show actual harm to a consumer, nor even actual toxicity; it’s sufficient to show that the food may cause harm.
The act specifically mentions food additives and pesticide residues. Color and other food additives are allowed in foods only if approved in advance by the FDA. Pesticide residues on foods must be within tolerances (limits) prescribed in advance by the Environmental Protection Agency, working in cooperation with the FDA. Foods not meeting these restrictions are deemed adulterated.
There are other criteria, besides actual content, that rise to the level of adulteration. If a food was prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with filth or become injurious to health, it is adulterated. This means that if inspectors find a dirty food processing plant, they don’t have to show that the plant’s output is also dirty. The condition of the premises themselves is sufficient to violate the prohibition on adulteration.
Other criteria that constitute food adulteration include:
- The container is composed of any poisonous or deleterious substance which may render the contents injurious to health
- It is, in whole or in part, the product of a diseased animal or one that died other than by slaughter
- Any valuable constituent has been omitted
- It has been intentionally subjected to radiation, except as specifically allowed by law
Labeling and Misbranding
The law imposes strict labeling requirements for processed foods, for the safety and education of consumers. Omitting required label information is called misbranding. The FDCA prohibits the sale of misbranded foods.7
The FDA does not preapprove individual product labels, but it establishes certain requirements. Labeling requirements have evolved over time as society’s health concerns have evolved. The traditional requirements are a list of basic ingredients, as well as quantity or volume. As concern about chemicals increased, disclosure of additives was required—such as artificial flavoring, coloring, or chemical preservatives. Now, a label must also have a nutrition panel, in easy-to-read format, showing information such as calories, dietary fiber, fat, carbohydrate and certain vitamin and mineral content. Among the latest developments, the panel must disclose transfat content, as well as certain ingredients strongly associated with allergies such as peanuts, wheat, cow’s milk, and shellfish.
The FDA regulates not just the contents, but also the format of food labels, including wording, size of type, and placement. This assures that important warning and educational information will not be hidden in the fine print.
The omission of required label information is not the only act that constitutes misbranding. The term also encompasses such wrongs as false and misleading statements or unauthorized claims of health benefits. Even certain nonverbal features constitute misbranding, such as containers that give the illusion of greater than actual volume, or a container designed to imitate another product.
Food Safety Modernization Act
In 2011 Congress enacted the Food Safety and Modernization Act (FSMA)8 in response to a number of nationwide food-borne disease outbreaks. This new legislation amends the FDCA to broaden federal enforcement powers and increase food safety planning and testing. The FDA has adopted regulations under this new authority. But the Office of Management and Budget (OMB), a White House office that regularly reviews agency regulations, made changes that have weakened that intended protection.
The FDCA is intended to protect public health by assuring that drugs, medical devices, and other medical products are safe and effective.9 Like other parts of the act, drug regulation involves science-based risk assessment and balancing of risks and benefits. This part of the act is highly precautionary, much more so than the food provisions.
As with other parts of the act, this part includes labeling requirements and uses the concepts of misbranding and adulteration. But for drugs, FDCA also requires rigorous premarket testing and review.
This discussion will focus on drugs, but much the same approach applies to other medical products, which include medical devices, biologics such as vaccines, blood products, and biotechnology products.
What Are Drugs?
The term basically refers to therapeutic drugs, both prescription and over-the-counter. The definition essentially incorporates everything recognized in the official US Pharmacopoeia and other specified compendia (encyclopedic listings).
But there is a broader functional definition as well, that goes beyond the Pharmacopeia. The statutory definition of drugs includes:
- Articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals
- Articles (other than food) intended to affect the structure or any function of the body of humans or animals10
Making advertising claims along these lines is tantamount to representing a product to be an FDA-approved drug. Thus it is a violation of the act to make such claims for any product not so approved. This is particularly relevant to dietary supplements, which are subject to far less stringent regulation than drugs.
Pre-approval of New Drugs
The FDA has responsibility for ensuring that therapeutic drugs and other medical products are safe and effective. One of the major tools for this purpose is the requirement that the FDA approve any new drug before it can be legally marketed in the United States.11 Drug manufacturers, which must be registered with the FDA, must conduct testing and submit extensive information as part of the approval process.12
Determination of Safety and Efficacy
The FDA will approve a new drug only if it determines that the product is safe and effective for its intended use. That determination is based on scientific testing and risk assessment. Essentially all drugs have some risks. Therefore, “safe” does not mean risk-free. The FDA must balance a product’s risks against its expected benefits.
Efficacy matters because, if a drug is not effective for its intended use, then its benefits are merely illusory and cannot outweigh even minimal risks. Indeed, an ineffective drug carries the extra risk that its user (or prescriber) will feel falsely secure and not seek a more effective treatment.
The manufacturer applying for approval of a new drug is responsible for providing adequate scientific evidence to demonstrate safety and efficacy. This requires rigorous, well-controlled studies, including clinical trials, all of which can cost the manufacturer millions of dollars and take years to complete.
There is an unavoidable tension between the desire to make promising drugs available as soon as possible and the need to protect consumer safety. The act is highly precautionary with respect to drugs, choosing to err on the side of safety. Even if existing scientific data is very promising, the FDA cannot approve a new drug until it is satisfied the data is adequate to demonstrate safety and efficacy. Although patient advocates sometimes become understandably impatient, such precaution has often prevented tragic outcomes.
Comparison to Other Laws
The regulation of drugs under FDCA is far more precautionary than the regulation of chemicals under the Toxic Substances Control Act (TSCA). Under TSCA, a new chemical can be freely marketed unless the EPA takes action within ninety days, and the EPA cannot require scientific testing without making a preliminary risk determination. By contrast, extensive testing is required for all new drugs, and they cannot be marketed without FDA approval.